ClearPoint Neuro, Inc.
Medical device manufacturer in Solana Beach, CA.
11510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243657 | ClearPoint System (Software Version 3.0)HAW · Traditional | 01/24/2025SE |
| K233703 | Bone Anchor (NGS-BA-01)HAW · Traditional | 04/26/2024SE |
| K233155 | ClearPointer Optical Navigation WandHAW · Traditional | 01/12/2024SE |
| K233144 | ClearPoint Bone Screw FiducialsHAW · Traditional | 01/12/2024SE |
| K233141 | SmartFrame ORHAW · Traditional | 01/12/2024SE |
| K233243 | ClearPoint System (Software Version 2.2)HAW · Traditional | 11/27/2023SE |
| K232102 | ClearPoint Array System (Version 1.2)HAW · Special | 09/15/2023SE |
| K222519 | ClearPoint SystemHAW · Special | 09/16/2022SE |
| K213645 | ClearPoint Maestro Brain ModelQIH · Traditional | 08/08/2022SE |
| K214040 | ClearPoint Array System (version 1.1)HAW · Traditional | 04/12/2022SE |
| K202575 | ClearPoint Array SystemHAW · Traditional | 01/22/2021SE |